510(k) · Cleared
ClearedEntarik NI Feeding Tube System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gravitas Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Nov 22, 2024 as substantially equivalent to K230206 (Gravitas Medical, Inc., 2023) and 2 other predicates after a 210-day review. Its family tree reaches back 5 generations to 1983. 1 of the 14 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 22, 2024
- Review
- 210 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K831868 (1983). 13 ancestors in all, the oldest K821906 (1982). No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK831868 Dobbhoff Feeding Tube W/Hydromer LubBiosearch Medical Products, Inc. · 1983
- 4 generations backK112511 Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012
- 3 generations backK123555 Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014
- 2 generations backK142327 smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015
- 1 generation backK230206 Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023
- This deviceK241169 Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024
Class I recalls in this family
- K113351 Cortrak Enteral Access Device3 generations back · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K831868 | Dobbhoff Feeding Tube W/Hydromer Lub | Biosearch Medical Products, Inc. | 1983 | — |
| −4 | K112511 | Dobbhoff Dual Port Feeding Tube | Covidien Lp, Formerly Registered AS Kendall | 2012 | — |
| −3 | K123555 | Kangaroo Feeding Tubes with Iris Technology | Covidien | 2014 | — |
| −2 | K142327 | smARTrack Feeding Tube System | Art Healthcare, Ltd. | 2015 | — |
| −1 | K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023 | — |
| 0 (this device) | K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 1 |
| 2013 | 2 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230206 | Entarik Feeding Tube System; Entarik Feeding TubeSummary page 5…eding Tube System is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K230206 Entarik Feeding Tube System / Gravitas Medical Inc. K202539 Nutriglide™ Nasal Feeding Tube / Appli… | 2023 |
| * | K202539 | Nutriglide (TM) Nasal Feeding TubeSummary page 5…umber Predicate Device Name / Manufacturer Primary Predicate K230206 Entarik Feeding Tube System / Gravitas Medical Inc. K202539 Nutriglide™ Nasal Feeding Tube / Applied Medical Technology, Inc. InnerSense Esophageal Tempe… | 2020 |
| * | K131590 | Innersense Esophageal Temperature Probe / Feeding TubeSummary page 5… K202539 Nutriglide™ Nasal Feeding Tube / Applied Medical Technology, Inc. InnerSense Esophageal Temperature Probe, Feeding K131590 Tube / Philips Medical Systems The predicate devices have not been subject to a design-related recall.… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K113351Cortrak Enteral Access DeviceCorpak Medsystems · 2012 · 3 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 41 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
Entarik NI Feeding Tubes (FTs) are intended for the administration of nutrition, fluids and medications by the nasoenteric or orogastric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Entarik NI Feeding Tube System (Entarik NI System) is designed to aid, in conjunction with institutional protocols, qualified operators in the…
Read the full statement (201 words)
Entarik NI Feeding Tubes (FTs) are intended for the administration of nutrition, fluids and medications by the nasoenteric or orogastric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
The Entarik NI Feeding Tube System (Entarik NI System) is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik NI Feeding Tube(FT) into the stomach of neonatal patients requiring enteral feeding. The Entarik FTs are equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik NI FTs are provided sterile.
The Entarik NI System also monitors the feeding tube position continuously during the course of feeding and automatically and in real time alerts of tube migration.
The Entarik NI System provides continuous monitoring of gastric and esophageal temperature. The Entarik device can be used solely for the purpose of monitoring gastric and esophageal temperature in situations where invasive monitoring is indicated.
The Entarik NI system is intended to record, store, view and analyze impedance in the pharynx, esophagus and stomach.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241169: Entarik NI Feeding Tube System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241169
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026